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Comparison Between 5-azacytidine Treatment and 5-azacytidine Followed by Allogeneic Stem Cell Transplantation in Elderly Patients With Advanced MDS According to Donor Availability


Phase 2
55 Years
70 Years
Open (Enrolling)
Both
Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia

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Trial Information

Comparison Between 5-azacytidine Treatment and 5-azacytidine Followed by Allogeneic Stem Cell Transplantation in Elderly Patients With Advanced MDS According to Donor Availability


Inclusion Criteria:



- Patients with proven de novo or therapy-related MDS / CMML (WBC <13 GPT/l)according
to FAB and risk profile according to IPSS: intermediate II- risk or high-risk or
intermediate I with high-risk cytogenetic (according to IPSS, taking into account
that IPSS, however, was not validated for t- MDS), patients with secondary AML
(according to WHO) and blasts ≤ 30 % (= RAEB-t according to FAB)

- Previously untreated or maximal 1 cycle of 5-azacytidine (Vidaza®)

- Male or Female; Age 55 - 70 years

- Understand and voluntarily sign an informed consent form

- ECOG performance status of ≤ 2 at study entry

- Adequate renal and liver function: creatinine and bilirubin < 3 x the upper limit of
normal

- Sufficient cardiac function (ejection fraction > 30 %)

Exclusion Criteria:

- Blasts > 30 % in bone marrow at time of diagnosis

- Central nervous involvement

- Severe irreversible renal, hepatic, pulmonary or cardiac disease, such as

- Total bilirubin, SGPT or SGOT ≥ 3 times upper the normal level

- Left ventricular ejection fraction < 30 %

- Creatinine clearance < 30 ml/min

- DLCO < 35 % and/or receiving supplementary continuous oxygen

- Pregnant or breastfeeding female subject

- Patients with a life-expectancy of less than six months because of another
debilitating disease

- Serious psychiatric or psychological disorders

- Uncontrolled invasive fungal infection at time of registration

- Known positive for HIV or acute infectious hepatitis, type A, B or C

- Participation in another study with ongoing use of unlicensed investigational product
from 28 days before study enrollment until the end of the study

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall survival

Outcome Description:

compare to overall survival of patients who receive after 4 cycles of 5-azacytidine either allogeneic stem cell transplantation or continuous 5-azacytidine if no compatible donor is available overall 230 patients

Outcome Time Frame:

three years

Safety Issue:

No

Principal Investigator

Nicolaus Kroeger, Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Medical Centre Hamburg-Eppendorf, Stem-Cell-Transplantation

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

VidazaAlloStudy

NCT ID:

NCT01404741

Start Date:

June 2011

Completion Date:

June 2017

Related Keywords:

  • Myelodysplastic Syndrome
  • Chronic Myelomonocytic Leukemia
  • MDS
  • CMML
  • allogeneic stem cell transplantation
  • 5-azacytidine
  • Leukemia
  • Leukemia, Myelomonocytic, Chronic
  • Myelodysplastic Syndromes
  • Preleukemia
  • Leukemia, Myelomonocytic, Acute

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